NCT06056752

QH103 Cell Injection for the Treatment of Relapsed/Refractory B-cell Acute Lymphoblastic Leukemia

A Dose-escalation Clinical Study of QH103 Cell Injection (CD19 CAR-γδT Cell Injection) in Patients With Relapsed/Refractory B-cell Acute Lymphoblastic Leukemia (B-ALL).

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 10 (estimated)
• Sponsor: Anhui Provincial Hospital · Other Government
• Sex: All
• Age: 14 Years
• Healthy volunteers: Not accepted

Summary

This is a single-arm, single-center, interventional, dose-escalation clinical study designed to evaluate the safety and tolerability of QH103 Cell Injection in the treatment of patients with relapsed/refractory B-cell acute lymphoblastic leukemia.

Detailed description

To evaluate the safety and tolerability of QH103 Cell Injection in the treatment of relapsed/refractory CD19-positive B-cell acute lymphoblastic leukemia, and to evaluate dose-limiting toxicity and maximum tolerated dose.

Conditions

• B-cell Acute Lymphoblastic Leukemia

Interventions

Type	Name	Description
BIOLOGICAL	QH103 Cell Injection	dose escalation (3+3) : dose 1 (3×10\^8CAR+cells) ,dose 2 (1 × 10\^9 CAR+cells）,dose 3 (3 × 10\^9CAR+cells)
DRUG	Fludarabine	Intravenous fludarabine on days-5\~-2,the infusion dose is adjusted according to the subject's condition
DRUG	Cyclophosphamide	Intravenous cyclophosphamide on days -5\~-3, the infusion dose is adjusted according to the subject's condition

Timeline

• Start date: 2023-09-27
• Primary completion: 2025-07-03
• Completion: 2026-07-03
• First posted: 2023-09-28
• Last updated: 2023-10-24

Locations

1 site across 1 country: China